Generic drugs: The benefits and risks of making the switch

Journal of Family Practice

Volumn 59, Issue 11, 2010, Pages 634-640

  Lewek, Pawel ^a   Kardas, Przemyslaw ^a  

^a MEDICAL UNIVERSITY OF LODZ   (Poland)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; ANTITHROMBOCYTIC AGENT; ANTITHYROID AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; GENERIC DRUG; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PSYCHOTROPIC AGENT;

ANTICONVULSANT THERAPY; ARTICLE; BIOEQUIVALENCE; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG MARKETING; DRUG RELEASE; DRUG SAFETY; DRUG SCREENING; DRUG SOLUBILITY; DRUG SUBSTITUTION; EPILEPSY; EVIDENCE BASED MEDICINE; HUMAN;

DRUGS, GENERIC; HUMANS; PHYSICIAN'S PRACTICE PATTERNS; THERAPEUTIC EQUIVALENCY;

EID: 78649372017     PISSN: 00943509     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. US Food and Drug Administration. What are generic drugs? Available at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/ UnderstandingGenericDrugs/default.htm. Accessed October 19, 2010.
2. Kesselheim AS, et al. Clinical equivalence of gneric and brandname drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300:2514-2526.
3. Zarowitz BJ. The generic imperative. Geriatr Nurs. 2008;29: 223-226.
4. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;133:332-337.
5. Briesacher BA, Andrade SE, Fouayzi H, et al. Medication adherence and use of generic drug therapies. Am J Manag Care. 2009;15:450-461.
6. Peters JR, Hixon DR, Conner DP, et al. Generic drugs - safe, effective, and affordable. Dermatol Ther. 2009;22:229-240.
7. European Agency for the Evaluation of Medicinal Products. Note for guidance on the investigation of bioavailability and bioequivalence. London, England: EMEA; 2000;CPMP/EWP/QWP/1401/98.
8. US Food and Drug Administration, Center for Research. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations, 2002. Available at: http://www.fda.gov/ cder/guidance/4964dft.pdf. Accessed January 11, 2009.
9. World Health Organization. Multi-source pharmaceutical products: WHO guideline on registration requirements to establish interchangeability. WHO Technical Support Series. Geneva, Switzerland: WHO;1996:TRS 863.
10. Meyer MC. Generic drug product equivalence: current status. Am J Manag Care. 1998;4:1183-1189.
11. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther. 2003;25:2875-2890.
12. Nakai K, Fujita M, Ogata H. International harmonization of bioequivalence studies and issues shared in common. Yakugaka Zasshi. 2000;120:1193-1200.
13. Randomized study of antiepileptic drag withdrawal in patients in remission. Medical Research Council Antiepileptic Drug Withdrawal Study Group. Lancet. 1991;337:1175-1180.
14. Crawford P, Feely M, Guberman A, et al. Are there potential problems with generic substitution of antiepileptic drags? A review of issues. Seizure. 2006;15:165-176.
15. Silpakit O, Amornpichetkoon M, Kaojarern S. Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients. Ann Pharmacother. 1997;31: 548-552. (Pubitemid 27203950)
16. Wangemann M, Retzow A, Evers G, et al. Bioavailability study of two carbamazepine-containing sustained release formulations after multiple oral dose administration. Arneimittel Forschung/Drug Res. 1998;48:1131-1137.
17. Besag FM. Is generic prescribing acceptable in epilepsy? Drug Saf. 2000;23:173-182
18. Liow K, Barkley GL, Pollard JR, et al. American Academy of Neurology. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology. 2007; 68:1249-1250.
19. US Food and Drug Administration. Bioavailability and bioequivalence requirements. FDA Code of Federal Regulations. 21.CFR320.33.
20. Henderson JD, Esham RH. Generic substitution: issues for problematic drugs. South Med J. 2001;94:16-21.
21. Swenson CN, Fundak G. Observational cohort study of switching warfarin sodium products in a managed care organization. Am J Health Syst Pharm. 2000;57:452-455. (Pubitemid 30127279)
22. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: http://www.accessdata.fda. gov/scripts/cder/ob/default.cfm. Accessed October 5, 2010.
23. Hennessey JV, Malabanan AO, Haugen BR, et al. Adverse event reporting in patients treated with levothyroxine: results of the Pharmacovigilance Task Force Survey of the American Thyroid Association, American Association of Clinical Endocrinologists and The Endocrine Society. Endocr Pract. 2010 Feb 11; 1-41. Epub ahead of print.
24. Calvert RT. Bioequivalence and generic prescribing: a pharmacy view. J Pharm Pharmacol. 1996;48:9-10.
25. British National Formulary: No. 31. London, England: Pharmaceutical Press; 1996.
26. Endrenyi L, Tothfalusi L. Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drag products? J Pharm Pharmaceut Sci. 2010;13:107-113.
27. Davies G. Changing the salt, changing the drug. Pharm J. 2001;266:322-323.
28. Meredith PA. Generic drags. Therapeutic equivalence. Drug Saf. 1996;15:233-242.